CRITIKON SOFT BLOOD PRESSURE CUFF

K974080 · Johnson & Johnson Medical, Inc. · DXQ · May 18, 1998 · Cardiovascular

Device Facts

• Record ID: K974080
• Device Name: CRITIKON SOFT BLOOD PRESSURE CUFF
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and semi-disposable (may be single-patient use or optional limited reuse). It is available in neonatal, pediatric and adult sizes. The device is not designed, sold, or intended for use except as indicated.

Device Story

Device consists of soft inelastic sleeve with integrated inflatable bladder; tubing connects to manual or automated noninvasive blood pressure measurement systems. Wrapped around patient limb; secured via hook and loop closure. Used in clinical settings by healthcare providers to facilitate blood pressure monitoring. Modification from predicate involves sleeve material change for improved patient comfort. Device provides pneumatic interface for pressure measurement; does not perform analysis itself. Benefits include patient comfort and compatibility with various sphygmomanometers.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, validation of reprocessing protocols per AAMI TIR No. 12-1994, and mechanical testing of repeated inflations to demonstrate safety and effectiveness.

Technological Characteristics

Soft inelastic sleeve with integrated inflatable bladder; hook and loop closure. Available in neonatal, pediatric, and adult sizes. Compatible with manual and automated sphygmomanometers via single or dual tubing configurations. Non-sterile, semi-disposable. Material modified for patient comfort.

Indications for Use

Indicated for use as an accessory with non-invasive blood pressure measurement systems in neonatal, pediatric, and adult patient populations.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• CRITIKON (formerly DISPOSA-CUF) Soft Blood Pressure Cuff (K790810)
• SURGI-CUF* Cuff (K883977)
• CUFF-ABLE Cuff (K911213)
• Cuff-m* Cuff (K921997)
• Soft Check* Cuff (K940214)
• Safe-Cuff* Cuff (Unknown)

Submission Summary (Full Text)

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# 1974080

## MAY 1 8 1998

| <b>510(k) Summary</b> |
|-----------------------|
|-----------------------|

| <b>Date</b> | October 27, 1997 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Contact</b> | Darlene T. Korab<br>Sr. Project Manager<br>Regulatory Affairs<br>Johnson & Johnson Medical, Inc.<br>4110 George Road<br>Tampa, FL 33634<br>Telephone: [phone]<br>Telefax: 813-887-2263<br>E Mail: [e-mail] |
| <b>Device Name</b> | CRITIKON* Soft Blood Pressure Cuff<br>The subject of this premarket notification is a modification of the currently<br>marketed Johnson & Johnson Medical, Inc. CRITIKON Soft Blood Pressure<br>Cuff (formerly DISPOSA-CUF* Soft Blood Pressure Cuff). |
| <b>Common Name</b> | Blood Pressure Cuff |
| <b>Classification</b> | The classification name, 21 Code of Federal Regulations (CFR) Part and<br>Paragraph number, product code and classification of the CRITIKON Soft<br>Blood Pressure Cuff follow. The tier categorization based on the list (January<br>27, 1994) distributed by the Office of Device Evaluation is also included. |

| Classification Name | 21 CFR Section | Product Code | Class | Tier |
|---------------------|----------------|--------------|-------|------|
| Blood Pressure Cuff | 870.1120 | DXQ | II | 2 |

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:

.

(12.05

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### 510(k) Summary, Continued

Predicate Devices

The CRITIKON Soft Blood Pressure Cuff is substantially equivalent to the CRITIKON (formerly DISPOSA-CUF) Soft Blood Pressure Cuff currently marketed by Johnson & Johnson Medical, Inc. The original DISPOSA-CUF Blood Pressure Cuff received market clearance on May 25, 1979 via Crest Medical Equipment 510(k) K790810. The device is virtually the same as the CRITIKON or DISPOSA-CUF Soft Blood Pressure Cuff . The CRITIKON Soft Blood Pressure Cuff is also substantially equivalent to the CUFF-ABLE* Blood Pressure Cuff currently marketed by Vital Signs, Inc. [Biomedical Dynamics 510(k) K911213] and other soft blood pressure cuffs.

| Device | Manufacturer | 510(k) |
|----------------------------------------------------------------|------------------------------------|---------|
| CRITIKON (formerly<br>DISPOSA-CUF) Soft<br>Blood Pressure Cuff | Johnson & Johnson<br>Medical, Inc. | K790810 |
| SURGI-CUF* Cuff | Ethox Corp. | K883977 |
| CUFF-ABLE Cuff | Vital Signs, Inc. | K911213 |
| Cuff-m* Cuff | Lorin Medical | K921997 |
| Soft Check* Cuff | Statcorp, Inc. | K940214 |
| Safe-Cuff* Cuff | CAS Medical Systems | Unknown |

#### Device Description

The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a noninvasive blood pressure measurement system.

The device is available in the following configurations:

- five neonatal and eight pediatric and adult sizes t
- single and dual cuff tubing, connectors, adapters and bulb/valve . assemblies available for use with a variety of manual and automated sphygmomanometers

Continued on next page

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## 510(k) Summary, Continued

(Individual of the state of the many of the same of

: 2018-08-08 11:2

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| Indications | The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction<br>with non-invasive blood pressure measurement systems. The device is non-<br>sterile and semi-disposable (may be single-patient use or optional limited<br>reuse). It is available in neonatal, pediatric and adult sizes. The device is not<br>designed, sold, or intended for use except as indicated. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The CRITIKON Soft Blood Pressure Cuff is virtually the same as the<br>CRITIKON or DISPOSA-CUF Soft Blood Pressure Cuff with the exception<br>of a modification of the sleeve material to afford greater patient comfort. The<br>CRITIKON Soft Blood Pressure Cuff is also virtually the same as the CUFF-<br>ABLE Blood Pressure Cuff and other soft blood pressure cuffs. All the above<br>devices are available in range of neonatal, pediatric and adult sizes and<br>configurations for use with a wide variety of manual and automated<br>sphygmomanometers. |
| Performance | Bench and laboratory testing was conducted to demonstrate performance<br>(safety and effectiveness) of the CRITIKON Soft Blood Pressure Cuff:<br>Biocompatibility<br>Validation of reprocessing<br>Repeated inflations |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR<br>Part 807, and based on the information provided in this premarket<br>notification, Johnson & Johnson Medical concludes that the modified device,<br>the CRITIKON Soft Blood Pressure Cuff, is safe, effective and substantially<br>equivalent to the predicate devices as described herein. |
| Other<br>Information | Johnson & Johnson Medical, Inc. will update and include in this summary<br>any other information deemed reasonably necessary by the FDA. |

・

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Johnson Johnson
MEDICAL INC.

October 6, 1997

Critikon, a division of Johnson & Johnson Medical, Inc., certifies that the instructions for reprocessing for CRITIKON™ Soft Blood Pressure Cuffs as available in the Instructions for Use (P/N 714338) have been validated according to a formal protocol (052496), comprising sound scientific principles and laboratory procedure. The protocol is conceptually based on AAMI TIR No. 12-1994, "Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers." A summary of the validation procedure is attached. The protocol and subsequent laboratory report are archived in Critikon Technical File 103-1 under change control. They will be made available for inspection or supplied to FDA upon request.

John P. Clemmons Critikon R&D

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

MAY | 8 1998

Ms. · Darlene T. Korab Johnson & Johnson Medical, Inc. 4110 George Road Tampa, FL 33634

Re : K974080 CRITIKON® Soft Blood Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ February 13, 1998 Dated: Received: February 17, 1998

Dear Ms. Korab ':

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Darlene T. Korab

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas A. Gelesh

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known):

Device Name: CRITIKON* Soft Blood Pressure Cuff

Indications for Use:

The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The device is non-sterile and semidisposable (may be single-patient use or optional limited reuse). It is available in neonatal, pediatric and adult sizes. The device is not designed, sold, or intended for use except as indicated.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stepe R. Campbell
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

¥ 974080 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use ﺎ، (per 21 CFR 801.109

OR

Over-The Counter Use (Optional Format 1-2-96)

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